mjewkes
Joined 14 years ago
Joined 14 years ago
This is because thinking, communication, and collaboration are extremely valuable.
In the short term, it drives up prices and makes consumers poorer. In the long run, tariffs shield companies from global competition and limit their ability to scale. Without that pressure or opportunity, businesses grow weaker—not stronger.
That weakens U.S. industry, not strengthens it.
https://en.wikipedia.org/wiki/2024_United_States_presidentia...
Yescarta, Kymriah, the mRNA vaccines, the approved VHH, scVF and “mimetics” in the article. Here’s a whole page of cell/gene therapies, many of these were produced “in their own way” or in ways that didn’t exist at all 10 years ago. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-t...
Warp speed did accelerate review of COVID vaccines, but it didn’t change trial design nor manufacturing requirements - I’m not sure that supports your argument. I have seen the FDA be quite receptive to innovative trial design - baysean protocols, conditional endpoints, genetic diagnostics in inclusion criteria, etc
If you think there is a whole wave of innovation being held back by the FDA - can you point to examples of drugs it rejected or innovations happening in any other country that should be happening here?
Lots of stem cell “medicine” is happening in Korea where the requirements on cellular medicine are more lax… none of that is translating to effective medicine here afaik.
As you say, biology is hard and messy! And it is the job of the FDA to prevent five 20 year olds in a garage from injecting desperate cancer patients with some hacked together MVP. We’re agreed on that.
But I just don’t see any evidence of a giant pool of untapped innovation at the preclinical level that the FDA is blocking.
If the FDA was not so strict in requiring evidence, medicine would look like the supplement aisle, and the incentive to actually do the stupidly hard work of developing effective drugs & proving their efficacy would disappear.
Why even bother investing in developing a complex new antibody if you can sell some mushroom powder from a beach and claim whatever you want about it, ala Tim Ferris & "BrainQUICKEN".
There are plently of valid "incremental" critiques about the FDA. IMO, their devices and diagnostics divisions are weaker than CDER and CBER. Even those two (drug focused) divisions can be too slow moving and occasionally capricious about when they want more evidence. But their final decisions are generally pretty good, with a few exceptions. And most of those exceptions are drugs that they approved that they shouldn't have (e.g. Aduhelm) - not vice versa.
Can you point at a promising drug candidate with statistically solid efficacy data that CDER or CBER has rejected?
Also - note that there are approved scFVs and VHHs and mimetics - as stated in the article. Each is useful in particular situations, but none is some sort of wild medical breakthrough. There is just no evidence that any of these modalities would be attracting extraordinary investment "if only it weren't for the FDA".
An exit for Employee < 50 at a netflix-to be will be in the hundreds of millions.
--
GPT-4 - wrong
gpt2-chatbot - wrong
Claude 3 Opus - correct
https://chat.openai.com/share/81e45fef-a72b-4258-98d6-5c8190...
It's actually hard to find short, simple, "plain english" failure cases like the above.
The "chain of reasoning" that the modern models deploy before the fail is funny too. This is GPT-4:
---
To determine the relationship between cherries and bananas based on your statements, let's break it down:
1. Apples are better than bananas.
2. Cherries are worse than apples.
From statement 1, we know apples rank higher than bananas. Statement 2 tells us cherries rank lower than apples. By this logic, since cherries are lower than apples, which are higher than bananas, it follows that cherries are also lower than bananas.Therefore, based on these comparisons, cherries are not better than bananas.
[...]
> After I finished writing this blog post, and had already sent it to Terry, OpenAI released a huge treasure trove of results in mathematics [including] the resolution of the so-called quasi Riemann Hypothesis
We ought to all be careful about underestimating the speed and magnitude of the change that is coming.
> if you are a student who is passionate to learn what is new and what is left to do, then a PhD is definitely the right path for you
This is an awful lot of confidence to put behind career advice in a wildly changing world. Markets are real and tradeoffs bite. We're not in gay communist space utopia yet.